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Promising future for Cubist's Sivextro in anti-MRSA sector

04-04-2014

Following its launch, Cubist Pharmaceutical’s second generation oxazolidinone Sivextro Sivextro will…

Antibiotics and Infectious diseasesCubist PharmaceuticalsDalvanceDurata TherapeuticsMarkets & MarketingoritavancinPharmaceuticalSivextroThe Medicines Company

UK’s NICE reverses negative decision on Roche’s Tarceva for NSCLC

04-04-2014

Following a consultation period, the UK drug watchdog the National Institute for Health and Care Excellence…

Northern EuropeOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

Actavis opens new Asia Pacific regional headquarters in Singapore

03-04-2014

Ireland-headquartered generics major Actavis has officially opened its new regional office in Singapore…

ActavisAsia-PacificGenericsManagementMarkets & Marketing

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

Astellas files for wider use of prostate cancer drug Xtandi in Europe

03-04-2014

Japanese drug major Astellas Pharma has submitted a variation to amend the Marketing Authorization Application…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

Fast growth forecast for South Korean pharma market

Fast growth forecast for South Korean pharma market

02-04-2014

South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in…

Asia-PacificBiosimilarsBiotechnologyMarkets & MarketingPricingResearch

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

Hikma’s US facility back in compliance

Hikma’s US facility back in compliance

02-04-2014

Hikma Pharmaceuticals, Jordan's largest pharmaceutical company, has received a close-out letter from…

GenericsHikma PharmaceuticalsJordanPharmaceuticalRegulation

European generic drug makers sets out priorities for EU Trade Policy

European generic drug makers sets out priorities for EU Trade Policy

02-04-2014

European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has…

EuropeGenericsPoliticsRegulationRest of the World

US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

01-04-2014

The global pancreatic cancer treatment market value in the six major countries (6MM: the USA, France,…

AbraxaneBiotechnologyCelgeneEuropeMarkets & MarketingOncologyUSA

Janssen files new NDA for combination HIV drug containing darunavir

Janssen files new NDA for combination HIV drug containing darunavir

01-04-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a New Drug Application…

Anti-viralsDarunavirJanssenPharmaceuticalPrezistaRegulationUSA

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

01-04-2014

Biotech firm Swedish Orphan Biovitrum has assumed direct responsibility for the distribution of its proprietary…

BiotechnologyMarkets & MarketingNorthern EuropeOrfadinRare diseasesSobi

US FTC releases 2013 highlights, including action against Actavis and Mylan

US FTC releases 2013 highlights, including action against Actavis and Mylan

01-04-2014

The US Federal Trade Commission chairwoman Edith Ramirez has released the agency’s 2013 Annual Highlights,…

ActavisMylan LaboratoriesPharmaceuticalRegulationUSA

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

Jazz Pharma and Gentium debut Defitelio in Europe

31-03-2014

Ireland-headquartered Jazz Pharmaceuticals and its Italian subsidiary Gentium have initiated the European…

AustriaDefitelioEuropeGentiumGermanyJazz PharmaceuticalsMarkets & MarketingPharmaceuticalRare diseases

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

31-03-2014

UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…

GlaxoSmithKlineOncologyPharmaceuticalRegulationUKVotrientWomen's Health

60 to 84 of 3671 results

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